The court documents allege that Eckard, who had recommended the factory be shut until the issues were resolved, communicated the quality violations at the plant in Cidra to David Pulman, president of global manufacturing and supply; Janice Whitaker, senior vice president of global quality; Peter Savin, vice president of global quality assurance; Diane Sevigny, director of global quality assurance, risk management and compliance; and Jonathan Box, vice president of manufacturing and supply for North America.
All five executives are believed to be still working for the London-listed company, while Pulman is also a member of the company's 18-strong corporate executive team, which includes chief executive Andrew Witty.
The whistleblower's evidence states: "Eckard now believes that Whitaker, Pulman and other GSK executives were unwilling to acknowledge the gravity of the violations at the Cidra plant and to take the action that Eckard had recommended in part because the FDA had indicated that it would not consider approvals for [GSK drugs] Avandamet and Factive until [a previous FDA warning was] resolved."
It further outlines how "on or about April 2, 2003, Eckard delivered to GSK senior managers Box, Savin, Whitaker and Sevigny … a non-routine detailed memorandum on Current Compliance Risks for Manufacturing and Supply of Drug Products at Cidra … She did not receive any response to her memorandum from any of the managers."
Eckard also states that she told Sevigny "that she would not participate in a cover-up … and would not take part in any further meetings with the FDA about the Cidra plant … During this period and thereafter, Eckard and Sevigny were in frequent and increasing conflict about GSK's management of the quality and compliance problems at Cidra."
Five GlaxoSmithKline executives who allegedly ignored Eckard believed to be still at company | Business | The Guardian
via guardian.co.uk
